Company
United StatesVirtex, Austin, TX – FDA Inspections
Inspection records and compliance data for Virtex in Austin, Texas. 3 FDA inspections on record, 1 Form 483, last inspected August 02, 2023.
Company Profile
This profile covers Virtex based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 26, 2013. Last inspected August 2, 2023.
Most cited issue areas
- Equipment control activity documentation1 inspection
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1214397 |
| September 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1025962 |
| March 26, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823538 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Virtex
FEI Number
3009403270
Address
16310 Bratton Ln, Austin, Texas 78728, United States
Country
United States
ID: de871f9d-5f39-48af-a2f5-e1a3c461e468